Multi-component vascular device

ABSTRACT

A vascular occlusion, flow restriction, shunt or filter device is disclosed comprising the assembly of at least two, of a number of selectable discrete interconnectable, interchangeable components, at least one component being of the type fabricated from metal strands braided into a tubular metal fabric having an expanded preset configuration and an elongated, collapsed reduced diameter configuration for delivery through a catheter to a treatment site and the device shaped to create an occlusion, flow restriction or shunt when placed in an opening in a body organ or vessel, the woven metal fabric having a memory property whereby the medical device tends to return to the expanded preset configuration when unconstrained.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 11/974,398, filed Oct. 12, 2007, which is incorporated hereinby reference in its entirety.

BACKGROUND OF THE INVENTION I. Field of the Invention

The present invention generally relates to collapsible therapeuticintravascular devices for treating certain medical conditions and, moreparticularly, relates to intravascular devices selectively configured ofdiscrete components for selective occlusion of a vessel or vesseldefect, shunting of flow, restricting flow or filtering flow in a vesselor organ, anywhere within the body's circulatory system. The devicesmade in accordance with the invention are particularly well suited fordelivery through a catheter or the like to a remote location in apatient's vascular system within a patient's body to occlude, shunt,restrict or filter blood flow.

II. Related Art

A wide variety of intravascular devices are used in various medicalprocedures. Certain intravascular devices, such as balloon catheters,diagnostic catheters, stent delivery catheters and guidewires, aregenerally used simply to navigate, deliver fluids or other medicaldevices to specific locations within a patient's body, such as aselective site within the vascular system. Other, frequently morecomplex, devices are used in treating specific conditions, such asdevices used in removing vascular occlusions or for treating septaldefects and the like.

In certain circumstances, it may be necessary to occlude a patient'svessel, chamber, channel, hole or cavity such as to stop blood flowthere through. In other cases, it may be necessary to create a flowrestriction or to shunt flow from one vessel to another to treatabnormal cardiovascular conditions. In still other cases, it may bedesirable to filter blood flow such as to prevent blood clots or embolifrom passing from one location in a vessel to another.

Examples of selective occlusion are, without limitation, closure of aPatent Ductus Arteriosus (PDA), Atrial Septal Defect (ASD), VentricularSeptal Defect (VSD), Patent Foreman Ovale (PFO), Arterial Venous Fistula(AVF), an Arterial Venous Malformation (AVM) or a Left Atrial Appendage(LAA).

Mechanical embolization devices are well known in the art and soldcommercially for occlusion of vessels in various locations within thevasculature. U.S. Pat. No. 6,123,715 by Amplatz and U.S. Pat. No.5,725,552 by Kotula disclose intravascular occlusion devices fabricatedfrom Nitinol braided metal tubular fabric which are heat set in molds toan expanded shape, but which can be compressed for delivery through acatheter to a treatment site, whereby the device, when urged out of thedelivery catheter, self expands within the vasculature to occlude bloodflow at the treatment site. The details of the various designs andconfigurations as well as methods of fabricating and using the devicesare detailed in the aforementioned patents which are deemed incorporatedin total herein by reference for any purpose.

An example of a shunting procedure is the shunting of blood between theportal vein and the hepatic vein, know as a Transjugular IntrahepaticPortosystemic Shunt (TIPS). Certain forms of congenital disease mayrequire a communication between the right atrium and left atrium.Shunting may also be required for treating specific abnormal conditions,such as bi-passing vascular occlusions within an internal passageway.U.S. Pat. No. 6,468,303 to Amplatz et al, also incorporated in itsentirety herein by reference for any purpose, describes catheterdeliverable shunt devices manufactured in similar fashion to thepreviously discussed occlusion devices and also details their design anduse.

Many defects that involve holes or openings in the septum of the heartallow blood to flow from the high pressure left ventricle to the lowerpressure right ventricle causing excess blood flow to the lungs. Thebody's natural reaction is to constrict the vessels to the lungs torestrict blood flow. Over time this causes a thickening of the pulmonaryarteries and ultimately to closure of smaller lung arteries and furthercomplications if left untreated. Examples of flow restriction devicesfor treating such a condition, their design and use, are found in U.S.Pat. No. 6,638,257 to Amplatz which is also deemed incorporated in itsentirety herein by reference for any purpose.

An example of a filtering procedure is a vena cava filter used toprevent passage of blood clots from the venous system to the lungs.Another filtering procedure involves prevention of emboli from balloonor stenting procedures from passage down stream into the heart whiletreating saphenous vein bypass grafts or preventing emboli from passingto the brain during carotid artery stenting procedures. An example of afiltering device for treating such a condition, it's design and use isfound in U.S. Pat. No. 6,123,715 to Amplatz and U.S. Pat. No. 5,725,552to Kotula as previously cited and incorporated by reference.

The occluding, shunting and flow restricting devices all use similartechnology for fabrication and each device as detailed is formed of asingle plurality of metal strands woven into a tubular braid. Due to thewide anatomical range of dimensions between premature infants and adultpatients, variations between patients of even the same body size, andconsidering the number of various treatment modalities, one canappreciate the enormous number of sizes and types of devices that needto be manufactured and inventoried by both the manufacturer and thehospital. This represents a large amount of capital sitting on the shelfuntil the need arises for a particular type and size of device. Toreduce inventory, would require that devices be ordered in advance asneeded. This presents a problem for emergency cases when there isafforded no time for waiting to treat a patient while a device ismanufactured or shipped from stock if available.

Therefore there is a need for medical devices of the class that can beassembled by either the manufacturer or preferably by the physician atthe point of use from an array of component parts that meets the needsof physicians without undue delay or inventory cost. Furthermore, thereis a need for a physician to be able to assemble a large number ofcustom devices suitable for a particular anatomical condition from avariety of components available in a medical device kit, or the like,made available at the point of use instead of stocking a large number ofvarious types and sizes of assembled devices.

The present advance in the art solves these problems in an advantageousmanner as will be explained in this specification.

SUMMARY OF THE INVENTION

By means of the present invention, collapsible therapeutic medicaldevices are supplied by assembly from a plurality of selected discreteparts, which devices are well suited for the selective occlusion,filtering, shunting, or flow restriction of a vessel, lumen, channel,cavity, or organ accessible from anywhere within the body's circulatorysystem.

The present invention provides a variety of vascular occlusion, filter,flow restriction, or shunt devices that can be easily fabricated by theassembly of at least two of a number of selectable individualinterconnectable components. Preferably, as needed for delivery, atleast one component is of a collapsible type fabricated at least in partfrom braided tubular metal fabric having a preset expanded configurationwhen unconstrained and an elongated reduced diameter collapsedconfiguration to enable delivery of a device using a vascular catheterto a treatment site. Such components are shaped to create an occlusion,filter, flow restriction or shunt device when placed in an opening in abody organ or vessel, the woven metal fabric exhibiting a memoryproperty whereby a medical device component fabricated using suchmaterial tends to return to an expanded preset configuration whenunconstrained.

Each of the components available for assembly into the device isprovided with a connection element on at least one end and preferably onboth ends to allow for inter-connectivity between or among a pluralityof components and to a delivery element or system. Each component iseither dimensioned to be passed through a delivery catheter or iscollapsible by elongation to enable passage through a delivery catheter.

A wide variety of component shapes and sizes are contemplated to allowassembly of devices to fit particular anatomical and treatment needs ofparticular patients. Each of a large number of sizes and types ofavailable parts or components are contemplated to be individuallypackaged for selective assembly into a full device at the time of use ina procedure. Preferably, components will be supplied in sterilizedpouches or trays although the components may also be sterilized by othermeans even at the hospital site.

In one embodiment of the device of the invention, the connections arethreaded and a given device is fabricated by threading one selectedcomponent onto mating threads on another selected component. Theproximal end of the assembled medical device is threaded onto a deliveryelement used to advance the device through a delivery catheterintroduced into the vasculature and placed adjacent the treatment site.The delivery system (also referred to as the delivery device or element)allows the assembled medical device to be passed out the distal end of acatheter lumen whereby the assembled medical device is enabled to returnto its preset expanded configuration. The assembled medical device of apreferred embodiment is further configured so that it remains attachedto the delivery system until detached by an operator and may be pulledback into the catheter by the delivery element, if needed, for example,to reposition the medical device or the medical device may be withdrawnback out of the body if it or a component of it is not of the correctsize. When the intravascular medical device is placed as desired, thedelivery element is unthreaded from it and removed along with thedelivery catheter from the body.

In accordance with the present concept, in the event that a device beingdeployed has one or more components found not to be the correct size,selected components may be readily replaced by different sizedcomponents obviating the need to change out the entire device. This canbe accomplished by unthreading the component and replacing it bythreading on a different selected new component. This enables one tocustomize aspects of the device by replacement of only necessarycomponents thereby enabling a cost saving over replacement of a completedevice.

One aspect of the invention is the provision of medical devicesassembled from selected multiple discrete interconnectable components,particularly those for treating vascular or organ abnormalities whichnecessitate occlusion, filtering, flow restriction or shunting as themeans of treatment.

Another aspect of the invention is the provision of a method of assemblyof medical devices using selected multiple components that may either beassembled by the manufacturer or assembled by the physician at the pointof use generally within the catheter lab of a hospital. When the medicaldevices are assembled by the manufacturer in this manner, savings occurby reductions of inventory to components that can be readily assembledto meet a wide variety of customer custom medical device needs. Thisreduces lead time between the order and shipment of devices andsimplifies the manufacturing process. When the device is assembled by aphysician from pre-sterilized components that are stocked in thehospital or readily available from a sales person or distributor, theneeds of any particular patient can be met when time is of the essencesuch as in an emergency.

In addition, the physician is able to assemble a custom device to meetthe particular anatomical needs of a patient that may be sufficientlyunusual so as to preclude the availability of a required assembledmedical device as a standard product offering. As previously mentioned,the perceived patient vessel or cavity size may be different inactuality from that determined by ultrasound or angiographic means. If adevice was ordered for a particular patient and, in the middle of theprocedure, the device is found not to fit, presently, the physician hasno option but to cancel the procedure and reschedule when the correctdevice is available or the physician would have had to order severaldevices of various sizes to reduce the risk of a misfit. This is costlyand unused devices increase inventory cost. On the other hand by use ofthe inventive in situ assembly of the device the physician can change acomponent of the system for another component during a procedure andcontinue the case to a successful conclusion.

In another aspect, the invention involves a method of treating medicalconditions necessitating the occlusion, filtering, flow restriction, orshunting of a vessel or organ within the body, by use of a medicaldevice comprising multiple discrete interchangeable components that areselectively interconnectable, either at the manufacturer or at the pointof use within a hospital catheter lab.

Many of the devices designed as occlusion devices have configurationsthat include flange or disk shapes at one end or spaced flange or diskshapes at both ends. Flange or disk shapes may be combined with othershapes adjacent to the flange or disk such as cylinders, taperedcylinders, etc. A spacer may be provided between two end disks orflanges that may have any number of shapes. The spacer may be coiled orlooped or be elastic to allow the overall device to accommodatevariations in the length of the path to be occluded. In many cases (butnot all) the spacer may be fabricated from a braided tubular fabric thathas a heat set memoried expanded state and a reduced diameter elongatedshape for passage through a catheter. It may be fabricated from Nitinolwire, or any of a variety of other memoried materials as will bediscussed. In some cases there is no spacer and the device takes on ashape more like a bell with a flange or disk end and an adjacent shortcylinder tapered at the distal end as shown in the above-referencedpatents. Flow restrictor and shunt devices may also have shapes thathave flange or disk-like members at one or more ends. Filters may havefunnel or disk-like members as well.

In accordance with another aspect of the present invention, commonshaped elements of a variety of current medical devices can befabricated as discrete components with connectors at one or both endsthat mate with compatible connectors on other components-such that asingle medical device can be fabricated by consecutive assembly in alongitudinal manner of a plurality of components end to end along acommon axis.

Another advantage of the concept is that each component of a device maybe fabricated using different materials and processes. In a one piecedevice all aspects of the device must be fabricated from the samebraided fabric. This may present limitations in the shape that can beobtained or limit the characteristics of the device. In amulti-component device each component may be fabricated to have aparticular set of characteristics that would not be obtainable from asingle braided fabric. For example, one component may have differentflexibility, elongation radial expansion force as by altering the numberof wires, wire diameter, material of the wires, or the pitch of thebraid. In a filter, one component may be specifically fabricated foranchoring properties while another component may be fabricated forfiltering particular sized emboli.

These and other features and advantages of the inventive design willbecome readily apparent to those skilled in the art from a review of thedrawings and the detailed description in conjunction with theaccompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Generally, FIGS. 1-26 represent prior art devices, but also representdesigns that could be fabricated using the multi-component deviceinvention disclosed herein. FIGS. 27-39 represent various componentsthat may be used to assemble devices using the invention.

FIG. 1 is a side view of a round double disk occluder having concavesurfaces on each disk, the concave surfaces being generally parallel;

FIG. 2 is a side view of a round double disk occluder having acylindrical central portion and concave surfaces on each disk in opposedor mirror image relation;

FIG. 3 is a side view of a round double disk occluder similar to FIG. 2but with reduced distance between the disks and a recess in one disk toaccommodate a securement means;

FIG. 4 is a side view of a round double disk occluder having one largedisk with a concave surface and a relatively smaller disk spaced tightlywithin the confines of the large disk;

FIG. 5 is a side view of a round double disk occluder having outwardfacing concave disks and a large diameter long central cylindricalsection between the disks, each of which has recesses for the securementmeans;

FIG. 6 is a side view of a round double disk occluder having a largedisk with a deep concave surface facing a smaller disk having a deepconcave surface and a loop connector between the disks;

FIG. 7 is a side view of a round double disk occluder having twodifferent diameter disks with shallow concave surfaces facing each otherand a small diameter long cylindrical section between the disks;

FIG. 8 is a side view of a double disk occluder similar to that of FIG.6 except that the disks have shallower concave surfaces and a coilconnector is provided between the disks;

FIGS. 9 and 10 are side and top views respectively of a shunt devicehaving an eccentric lumen and two disks with recessed securementconnectors;

FIG. 11 is a side view of a round occluder having a single flange and atapered diameter portion adjacent with recessed surfaces to accommodatethe securement element;

FIGS. 12 and 13 are side views of round occluders having a disk at oneend, recessed surfaces at each end for the securement means or element,a rounded flange at the opposite end and a large diameter, longcylindrical central portion with the disk of FIG. 12 located eccentricto the central portion;

FIGS. 14A and 14B are side and installed use views, respectively, of around flanged occluder with a tapered length;

FIGS. 15 and 16 are side and top views of a bell shaped PDA (PatientDuctus Arteriosus) occluder having a single fabric layer construction;

FIGS. 17 and 18 are top and side views of a flanged occluder;

FIGS. 19 and 20 are side and top views respectively of an occludersimilar to that of FIG. 1 but fabricated with multiple layers of fabric;

FIGS. 21 and 22 are side and top views, respectively, of an occludersimilar to that of FIGS. 15 and 16 but fabricated of multiple layers offabric;

FIG. 23 is a perspective view of a collapsible medical device for use asa flow restrictor shown in its expanded state;

FIG. 24 is a side view of the occluder of FIG. 7 occluding a passagewayin the body;

FIG. 25 is a side view, with parts cut away, of an occluder shownoccluding an aneurysm;

FIG. 26 is a sectional view of the heart showing a PDA (Patent DuctusArteriosus) occluder in use;

FIGS. 27A-I illustrate a plurality of examples of various disk shapeddiscrete components in accordance with the invention;

FIGS. 28A-G illustrate a plurality of examples of spacer and otherdiscrete components in accordance with the invention;

FIG. 29 is a side view of a discrete cylindrical component havingrecessed areas on both end surfaces for securement connectors;

FIG. 30 shows a side view of a discrete component for a PDA occluder;

FIG. 31 shows a side view of a discrete component of an occluder for avessel or cavity;

FIG. 32 shows a side view of a discrete component of a flanged occluder;

FIGS. 33A-B show a top/end view and a sectional view, respectively, of adiscrete component of a flow restrictor or a shunt device;

FIGS. 34A-B depict side and end views of a filter device component foruse in a body channel;

FIGS. 35A-B are cross-sectional views of a screw connector witharticulation shown disassembled in FIG. 35A and assembled in FIG. 35B;

FIG. 36 is a cross-sectional view of a ball & socket connector witharticulation;

FIGS. 37A-B are side and end views respectively showing a clamping orsecurement connector device securing ends of a metal fabric;

FIGS. 38A-C show parts for securement connector devices in accordancewith the invention; and

FIG. 39A-C are enlarged views of threaded adapters including amale/female thread adapter 34 (A) a male to male thread adapter 34 (B)and a female to female thread adapter 34 (C).

DETAILED DESCRIPTION

The present invention provides vascular occlusion, filtering, flowrestriction, or shunt devices made up of the assembly of at least two,of a number of selectable individual components, at least one componentbeing of the type fabricated from metal strands braided into a tubularmetal fabric (described below) having an expanded preset configurationand an elongated, collapsed reduced diameter configuration for deliverythrough a vascular catheter to a treatment site wherein the device isshaped to create an occlusion, flow restriction or shunt when placed inan opening in a body organ or vessel, the woven metal fabric having amemory property whereby the medical device tends to return to anexpanded preset configuration when unconstrained.

The metal strands define two sets of essentially parallel generallyhelical strands, with the strands of one set having a “hand”, i.e. adirection of rotation, opposite that of the other set. This defines agenerally tubular fabric, known in the fabric industry as a tubularbraid. The Amplatz and Kotula patents previously discussed describetubular fabric medical devices and the methods of fabrication of suchdevices in great detail and further detailed discussion is believed notneeded here.

The pitch of the wire strands (i.e. the angle defined between the turnsof the wire and the axis of the braid) and the pick of the fabric (i.e.the number of wire crossovers per unit length) may be adjusted asdesired for a particular application. The wire strands of the metalfabric used in the present method should be formed of a material whichis both resilient and which can be heat treated to substantially set adesired shape. Materials which are suitable for this purpose include acobalt-based low thermal expansion alloy referred to in the field asElgeloy, nickel-based high temperature high-strength “superalloys”commercially available from Haynes International under the trade nameHastelloy, nickel-based heat treatable alloys sold under the nameIncoloy by International Nickel, and a number of different grades ofstainless steel. An important factor in choosing a suitable material forthe wires is that the wires retain a suitable amount of the deformationinduced by a molding surface (as described below) when subjected to apredetermined heat treatment.

One class of materials which also meet these qualifications includesso-called shape memory alloys such as Nitinol, an approximatelystoichiometric alloy of nickel and titanium, which may also includeminor amounts of other metals to achieve desired properties. Such alloystend to have a temperature induced phase change which will cause thematerial to have a preferred configuration which can be fixed by heatingthe material above a certain transition temperature to induce a changein the phase of the material. When the alloy is cooled back down, thealloy will “remember” the shape it was in during the heat treatment andwill tend to assume that configuration unless constrained from so doing.These alloys are also very elastic and have been described as“superelastic” or “pseudoelastic”.

As an example, without limitation, the device can be illustrated beingfabricated from 32 braided nitinol wires having a diameter ranging from0.0015-0.008 inch (0.0381-0.203 mm), preferably 0.002-0.005 inch(0.051-0.127 mm). The number of wires to be braided may range from 4-200or more, preferably from 8 to 144 and, more preferably, from 16-72depending on the particular device characteristics desired. A typicalpitch angle may range from 30-70 degrees from the longitudinal axis ofthe braided tube in the, as braided, relaxed tube prior to heattreatment. As indicated, the pitch, pick count (number of wirecrossovers per inch, or other lineal measure) and wire diameter, are allvariables that can be altered to change the device characteristics aswell as the heat set shape.

In forming a medical device component in accordance with the invention,an appropriately sized piece of the metal fabric is cut from the largerpiece of fabric which is formed, for example, by braiding wire strandsto form a long tubular braid, as has been described. When the fabric iscut to the desired dimensions, care should be taken to ensure that thefabric will not unravel.

Thus, the ends at the selected desired length may be soldered, brazed,welded or otherwise affixed together (e.g. with a biocompatiblecementitious organic material) before the braid is cut.

Once an appropriately sized piece of the metal fabric is obtained, thefabric is deformed to generally conform to a surface of a moldingelement. The forming of the fabric re-orients the relative positions ofthe strands of the metal fabric from their initial order to a second,re-oriented configuration. The shape of the molding element should beselected to deform the fabric into substantially the shape of thedesired component of the medical device.

Once the molding element is assembled with the metal fabric generallyconforming to a molding surface of that element, the fabric can besubjected to a heat treatment while it remains in conforming contactwith that molding surface. After the heat treatment and cooling, thefabric may be removed from the molding element and it will substantiallyretain its deformed molded state. Suitable heat treatments of Nitinolwire, for example, to set a desired shape are well known in the art. Ithas been found that holding a Nitinol fabric in the range of about 500°C. to about 550° C. for a period of about 1 to about 30 minutes,depending on the softness or harness of the device to be made, will tendto set the fabric in its deformed state, i.e. wherein it conforms to theshape of the molding surface of the molding element. At lowertemperatures, the required heat treatment time will tend to be greater(e.g. about one hour at about 350° C.) and at higher temperatures thetime will tend to be shorter (e.g. about 30 seconds at about 900° C.)

The ends of the braided metal fabric device component are generallywelded or clamped together with clamp securements to avoid fraying. Ofcourse the ends may alternately be held together by other means readilyknown to those skilled in the art. Alternatively, one end may befabricated without the clamp as in the case of a conical filter, such asis shown in FIGS. 34A and 34B, since the heat set shape will resistunraveling of the strands.

As used herein, the terms securement, securement means, securementdevice, etc., refer to any device or technique including welding or useof adhesives, etc., to secure the ends of the braided metal fabric.Connector clamp, clamp connector, retaining connector, securementconnector, etc., may be used interchangeably to refer to any devices ortechnique designed to retain the ends of the braided metal fabric andprovide a connection with an adjacent component. The securement at anend, which ties together the wire strands, may also serve to connect thedevice component to other device components or to a delivery system. Ina preferred embodiment, end clamps or securements are provided that arealso part of the connectors and are generally cylindrical in shape andhave a recess for receiving the ends of the metal fabric in a mannerthat substantially prevents the wires comprising the woven fabric frommoving relative to one another. The securement connectors also aregenerally provided with a threaded surface. Either external (male) orinternal (female), threads may be provided or, alternatively, any of anumber of other connecting techniques known in the art may be employedto reversibly attach one component to an adjacent component in amulti-component device or to a delivery system. An ability for reversalor disassembly, while not mandatory, preferably should also befacilitated.

FIGS. 1-26 generally depict examples of some devices that can befabricated using the inventive concept for the assembly of at least twocomponents, such as those illustrated in FIGS. 27-33.

More particularly, FIGS. 1-8 illustrate a variety of designs that may bedescribed as having axially aligned flanged or disk elements, one ateach end, with a connective member positioned between them. The shapeand size of the connective members may vary widely from very thin loopor coil sections to heavy cylindrical sections and from very short tovery long sections. The devices of FIGS. 9-26 generally could bedescribed as devices having a flange or disk at one end only with anadjacent connecting shape attached thereto.

FIG. 1 is a side view of a round double disk occluder 10 having concavesurfaces on each disk 12 and 14 with the concave surfaces beinggenerally parallel. A cylindrical central portion is shown at 16.

FIGS. 2 and 3 show similarly shaped round double disk occluders 18 and18 a, respectively. The disks 20, 22 and 20 a and 22 a have opposedconcave inner surfaces. These devices have cylindrical central portionsas at 24 and 24 a, respectively, with the central portion 24 beinglonger than the central portion 24 a. External securement connectors areshown at 26, 28 and 26 a and 28 a, respectively. FIG. 4 depicts a sideview of a round double disk occluder 30 having one large disk 32, with aconcave surface and an opposing smaller disk 34 that is spaced tightlywithin the confines of the large disk. External securement connectorsare provided as at 36.

FIG. 5 is a side view of a round double disk occluder generally at 40having spaced outward facing concave disks 42 and 44 and a largediameter long central cylindrical connecting section between the disksshown at 46. The disks are provided with recesses which incorporatesecurement connector elements as at 48.

FIG. 6 is a side view of a round double disk occluder 50 includingopposed disks. A large disk 52 with a deep concave surface faces asmaller disk 54, also having a deep concave surface. These are connectedby a rather long loop connector 56. External securement connectordevices are shown at 58. FIG. 8 is a side view of a double disk occluder60 which is similar to that of FIG. 6 except that the disks 62 and 64have shallower concave surfaces formed by a looped coil 66 is shownattached between the disks. External clamps or securement connectors arealso shown at 68 and 68 a.

FIG. 7 is a side view of a round double disk occluder 70 having twodisks 72 and 74 of different diameters featuring opposed shallow concavesurfaces facing each other with a rather long cylindrical section 76connecting the disks. External securement connectors are shown at 78 and78 a. FIG. 24 represents a view of the occluder 70 of FIG. 7 deployed toocclude a defect 186 in a vessel wall or membrane at 188.

FIGS. 9 and 10 are side and top views, respectively, of a shunt device80 connected by an eccentric large diameter cylinder having a lumen 82and two disks 84 and 86 with recessed securement connectors 88.

FIG. 11 is a side view of a round occluder 90 having a single flange 92and a tapered diameter adjacent component portion 94 with recessedsecurement connectors 96. FIGS. 12 and 13 are side views of singleflange similar round occluders 100 and 100 a having a disk 102 at oneend and recesses 104 and 106. The occluder 100 further includes arounded flange 108 and a large diameter, long cylindrical centralportion at 110. The disk 102 in FIG. 12 is eccentric to the centralportion 110.

FIGS. 14A and 14B are side and installed views, respectively, of round,multi-flanged occluders with a tapered length. Securement connectors areshown at 122 and 124. That device contains consecutive, spaced conclaveflanges of increasing sizes as shown at 126, 128 and 130. They arejoined by conical internal sections 132 and 134. An outer cylindricalsection is provided at 136. In FIG. 14B, a similar two-flanged device138 is shown installed to occlude a defect at 139.

FIGS. 15 and 16 are side and top views, respectively, of a bell-shapedPDA occluder 140, which is fabricated using a single layer of fabric andincludes a recessed flange 142 and securement and connecting devices at144 and 146. FIGS. 21 and 22 are side and top views, respectively, of anoccluder 150 similar to that shown in FIGS. 15 and 16, but fabricatedusing multiple layers of fabric. FIG. 26 is a sectional view of theheart showing a PDA occluder 200 in place in a heart 202.

FIGS. 17 and 18 represent top and side views of a single flangedoccluder 160 with side securement connectors at 162 and 164. FIGS. 19and 20 are side and top views, respectively, of an occluder very similarto that shown in FIG. 1 fabricated with multiple layers of fabric.

FIG. 23 depicts a perspective view of a collapsible flow restrictordevice 180 in its expanded state.

FIG. 25 is a side view, with parts cut away, of an occluder 190occluding an aneurism in a vessel at 192. Securement connectors areshown at 194 and 196.

FIGS. 27A-I through FIG. 36 and FIGS. 39A-C illustrate examples ofcomponents likely to be assembled into multi-component devices such asthose illustrated in FIGS. 1-26 according to the invention. FIGS. 27A-Iare illustrations of example flange or disk-shaped components 300-315selectable to be incorporated in a final device. Each of the flange ordisk components illustrated in FIGS. 27A-I are provided with a pair offemale threads in securement connectors at each end as at 316 and 318 offlange 300. Component 315, shown in section, is provided with a singlefemale connector through the proximal side. While the clamp orsecurement extensions containing the female threads may be larger as at320 in flange 308, the female threads as at 322 in flange 308 arepreferably all of a uniform size to accommodate a variety of theconnector devices having a common thread size. Examples of such devicesare shown in FIGS. 28A-G as at 350, 352, 354, 356, 358, 360 and 361.These may range from loop connectors as in FIG. 28C, rather largediameter straight or tapered cylinders as at 356 and 358, respectively.A round shape is shown at 360 in FIG. 28F and a spring component at 361.In this regard, however, as with the flange and disk parts of FIGS.27A-I, male threaded connectors as at 362 and 364 of FIG. 28A areprovided with a common size and threading and all of the devices ofFIGS. 28A-F and which correspond to the female threads of FIGS. 27A-I.

Other parts are shown in FIGS. 29-33. Thus, in FIG. 29 there is shown aside view of a discrete cylinder component 380 having recessed areas onboth end surfaces for securement devices and being supplied withthreaded securement connectors at 382 and 384. In FIG. 30, there isanother view of a single layer discreet component for a PDA occluder at390 and having male threaded connectors on both ends at 392 and 394.

FIG. 31 depicts a component of a rounded occluder suitable for a vesselor cavity at 400 with male threaded securement connectors at 402 and404. FIG. 32 depicts a double flange component of a flanged occluder at410 with male threaded securement connectors shown at 412 and 414.

FIGS. 33A and 33B depict a top/end view and a sectional view,respectively, of a discreet component 420 of a flow restrictor or shuntdevice with recessed threaded securement connectors shown at 422 and424.

FIGS. 34A and 34B depict an embodiment of a component suitable for useas a filter for a body cavity such as a blood vessel or other cavity.The filter 450 has a generally conical configuration tapering generallyradially outward from a first and end 452 which is shown clamped in athreaded male connector 454 to a forward or second end 456 which isflared and sized to completely fill the channel to be filtered. Fabricends 458 are shown unsecured.

The views of 37A and 37B and 38A-C depict a typical securement connectordevice 460 which includes an outer tubular member or sleeve 462 and aninner tubular member or sleeve 464. The combination of the outer sleevemember or sleeve 462 and sleeve member 464 cooperated to clamp andsecure fabric end fibers as at 466 therebetween. The sleeve member 464is also provided with a female thread at 468 to connect to an adjacentinterconnectable component or a delivery device or system.Alternatively, the inner member may be provided with a male threadconnection as shown at 470 in FIG. 38C.

FIGS. 39A-C are slightly enlarged views of a male/female thread adaptor430 in view 34A; a male to male thread adaptor 432 shown in view 34B; afemale to female thread adaptor 434 shown in view 34C.

The clamp connectors that are attached to components as shown in FIGS.27A-I and 34A and B, or the like, for example, are, as described above,fabricated using inner and outer sleeves. A female inner sleeve has abore that is threaded with a given thread such as 000-120. A secondouter sleeve has an inside diameter of sufficient size to accommodatethe braid fabric end wires as well as the outside diameter of the innersleeve. Once the wire ends are positioned between the two sleeves theassembly is laser welded together.

In the case of the end securement clamp connector attached to the middleor adjacent components as in FIGS. 28A-G, for example, the securementclamp connector is similarly fabricated from an inner and outer sleevein a similar manner, except that the inner sleeve has a male thread thatmates with the female thread of the securement clamp connectors of FIGS.27A-H.

FIGS. 28A-G describe either middle or adjacent components designed toattach to those shown, for example, in FIGS. 27A-I and FIGS. 34A and B.The middle components provided with male threads as extensions to theirwire end securement clamps or other securement devices. These componentsreadily assemble by threaded engagement to those of FIGS. 27A-I. Tofabricate a device, for example, that shown in FIG. 7, one would threadcomponent 380 of FIG. 28A into one end of component 300 of FIG. 27A, andthe opposite end of component 350 to component 302 of FIG. 27B. Eitherend of the assembled device can then be threaded to a delivery systemhaving a male thread on its distal end.

Of course, any of the components illustrated as having male threadscould be provided with female threads and vise versa, or each devicecould have a male thread on one end and a female thread on the otherend. The latter combination, however, is not the preferred embodiment asit is less flexible to assembly choices. In other embodiments, allcomponents could be of either all male thread or all female threads. Inthis arrangement, it would be necessary to use thread adapter componentsas shown in FIGS. 34A-C. Since these components are small and may bedifficult to handle, this construction is not the preferred embodiment,but is contemplated since it allows all devices to be fabricated withsimilar end wire clamp securement connectors. Still, this allowsassembly of combination devices where otherwise a thread mismatch mightoccur with available parts, as during a procedure.

Notwithstanding the above, it will be appreciated that other means ofpreventing the fabric wire end from unraveling may be used such ascrimping, use of adhesives, soldering, brazing etc. A suitable threadedconnector is still advised in the preferred embodiments but is notrequired. One may use any other connection means suitable for theapplication as is known in the art. Alternatively, if the fabric isinverted at one end, the two wire ends may be brought together one atopthe other and secured by a single clamp connector as illustrated in FIG.27I. Additionally, the clamp may be removed from one end altogether withthe wires heat set shape resisting unraveling though this is not apreferred configuration as illustrated in FIGS. 34A and B.

For example, FIGS. 35A-B and 36 illustrate two alternative connectorsthat may be used to prevent the fabric wire ends from unraveling andalso to connect components together in an articulated manner. In FIG.35B, the assembled clamp connector 520 is shown with a male threadedconnector 524 threaded through threads 526 of the female connector 522into cavity 528 such that the threads 530 of male connector 524 are nolonger engaged. This permits male connector 524 to pivot about inconnector 522. Cavities or recesses 532 and 534 are provided forretaining braided wire ends by crimp, weld, adhesive or other means.Components as shown in FIGS. 27A-H may, for example, be fabricated usinga female wire end securement connector as at 522 on each end and thecomponents shown in FIGS. 28A-G and FIGS. 29-34B may employ the malewire end retaining connector as at 524. The components may then beconnected by threading action to one another. By threading thecomponents through and beyond the internal threads 526 as shown in FIG.35B, the assembly allows articulation between the members as shown bythe arrow at 536. If this is not desired, the threads of each componentmay be allowed to remain engaged using fewer assemble turns betweencomponents.

FIG. 36 shows a cross-sectional view of a ball and socket end wireretaining connector 540 including a ball end component 542 and a socketend component 544 with wire end connection cavities 546 and 548,respectively, which may be similar to cavities 532 and 534. Assembly ofthe clamp connector device of FIG. 36 is achieved by compressing theball 550 of ball end component 542 into the socket 552 of socketcomponent 544 until they snap together. The socket 552 is provided withlongitudinal slots (not shown) through the cylindrical wall 554 whichallows it to deform sufficiently. The holding force between theassembled ball and socket connector 540 must be greater than the loadexperienced during implantation to ensure that the assembly remainsintact. The ball and socket allows the assembled components toarticulate as needed in any direction to align to anatomical conditionsas indicated by arrow 556.

As indicated, the thread adapters of FIG. 39A-C are male to female(39A), male to male (39B) and female to female (39C). These adaptersallow assembly of some components that otherwise may not beinter-connectable because of male/female thread mismatches and provideflexibility in creating a device shape and size.

It should be noted that, while the components to the device as shown inFIGS. 27A-34B are all shown fabricated of braided fabric, this is forillustration purposes only. Non-braided components are anticipated aswell. For example, elastic middle components may be fabricated fromsprings including metal springs and non-metal elastic, resilientmaterials. The springs may be either tension or compression devicesdepending on the application, but generally will be tension springsseeking to pull the flange members toward each other as this isdesirable for most applications. Polymers such as polyurethane orsilicone or other polymers may also be used. The non-braided componentssimilarly can be provided with compatible threaded end connectors, butthe connectors may be fabricated differently from those for braidedcomponents. Individual components can incorporate polymeric strands aswell as metal strands braided together or otherwise connected as bysuture to one another.

It is anticipated that, in addition to the shapes shown in the drawingFIGS. 27A-33B, an array of sizes for each shape could be offered as wellas additional shapes not shown for new applications or differentanatomical conditions. In addition, it is anticipated that a device maybe fabricated using multiple middle components to extend length withoutan end flange or disk. Multiple components such as that of FIG. 33Aassembled together may form a flow restrictor or a shunt. Multiplecomponents such as shown in FIG. 28A may form a long vessel occluder. Insuch a case, the diameter of the component would generally be sizedlarger than the vessel by approximately 10-30% to enable the vessel toretain the device in place.

In other configurations, components as at 310 in FIG. 27F and 360 inFIG. 28F may be assembled to fabricate a device as is shown in FIG. 25for use in occluding an aneurysm. Combining component 390 in FIGS. 30and 354 in FIG. 27C results in a device similar to that shown in FIGS.15 and 21 for occluding a PDA. As indicated, FIG. 21 illustrates amulti-layer fabric device and FIG. 15 a single layer fabric device. Allthe components shown in FIGS. 27A-34B may be fabricated with one layeror multiple layers whereby any layer may be made of metal or polymerstrands or a combination thereof. As additional component offerings, thebraid wire diameter, pick and pitch may be altered as well for differingproperties to affect stiffness, conformability, deliverability,collapsed profile or rate of thrombosis. Those skilled in the art willappreciate that in order to speed up the occlusion of a vessel, forexample, the device may be coated with a suitable thrombogenic agent,filled with a polyester fiber layer or braided with an increased numberof wire strands. Devices have been made preferably using a polyesterfiber layer placed within the braided device and sutured in place. Thislayer may be a braided, knit or woven separate polyester filament. Inthis embodiment, the polymer layer is placed within or possiblyoverlaying the metal braided structure and sutured to the metalstructure. If the polymer fabric is braided using a similar pitch andpick count for both the metal braid and polymer braid, the device caneasily collapse and self expand as a unitary device for delivery using acatheter. A device using a fiber layer is also the preferred embodimentfor an occlusion device, although use of multiple-layers of braided wirefabric may function in a similar manner to the polyester fabriccombination to speed thrombosis. The interwoven fiber by its attachmentto a clot retains the clot firmly within the device as it forms anocclusion.

The tubular braid used to fabricate occlusion devices, for example,using this invention may range from wire having a diameter of 0.002 to0.005 inch, preferable in the range of 0.003 to 0.0035 inch and for aPDA device preferably 0.003 inch diameter. The number of wires in thetubular braid may vary from 36 to 144 but preferably is in the range of72 to 144 and for a PDA device is preferably 144 wires. The pick countof the braid may vary from about 30 to about 100 and preferably fromabout 50 to about 80 and for a PDA device is most preferably about 70.

It is of an additional benefit to the assembly of multiple components ifthat the connectors of the assembled devices are of a small diameter andpositioned at the axis of the device so that the flange or diskcomponents can easily flex about the connectors and adjacent componentsto improve the conformability of the device to variable anatomicalconditions.

In accordance with the use of the invention herein, the physician firstassesses the anatomical situation of a patient in the catheter lab todetermine the size and configuration of a device that would be best forthe patient. The physician may then select individual componentspre-steriled and stored in tyvek pouches, or the like, to be assembledin the catheter lab. A separately available device delivery system anddelivery catheter may be selected as well. Delivery devices or elements(not shown) are well known and can take any suitable shape, preferablycomprising an elongated flexible metal shaft or cable similar to aconventional guidewire or may be a hollow shaft, either configurationhaving a distal threaded connector. The individual device components areassembled in the sterile field by threading them together somewhattightly. The delivery device may be placed through the delivery cathetersuch that the distal threaded end extends beyond the end of the deliverycatheter. The proximal end of the assembled intravascular medical deviceis then threaded loosely onto the delivery system. In this manner, thedelivery element may be back-loaded into the delivery catheter prior toplacement of the delivery catheter into the body by proximal movement ofthe delivery device relative to the delivery catheter. When the medicaldevice is withdrawn into the catheter, it is stretched axially, whichallows the medical device profile to be reduced and the medical devicepulled into the catheter. The catheter, delivery element and deliverysystem are now in a configuration for delivery into the body by normalcatheter introduction techniques.

Alternatively, the delivery device may be back drawn into the distal endof a tear-away tapered introducer sleeve to reduce its diameter and thenforward loaded into the proximal end of the delivery catheter. Thisprocedure is preferred if the delivery catheter has already beenintroduced into the body of the patient.

A delivery device can also be used to urge the assembled medical devicethrough the lumen of a catheter, or alternatively, through a longintroducer sheath for deployment in a channel of the patient's body.When the assembled medical device is deployed out of the distal end ofthe catheter adjacent the treatment site, the assembled medical deviceis still attached to and retained by the delivery device. Once theproper position of the assembled device in the vessel or other locationis confirmed, the shaft of the delivery device can be rotated about itsaxis to unscrew the connected clamp connector from the delivery device.Of course, the threaded connection may be at either end of the devicedepending on the anatomical situation and the desired or available meansof access to the treatment site.

The torque used to assemble and retain the device components to eachother must be higher than the unthreading torque required to separatethe delivery system from the assembled device. This is usuallyaccomplished by a stop in the delivery system threads designed tocontrol the maximum torque applied.

By keeping the medical device attached to the delivery system untilproper placement and size are confirmed, the operator can still retractthe medical device for repositioning if it is determined that themedical device is not properly positioned in the first attempt or thatthe size of one or more components needs to be adjusted. This threadedattachment technique also allows the operator to control the manner inwhich the device is deployed out of the distal end of the catheter. Whenthe medical device exits the catheter, it will tend to resilientlyreturn to a preferred expanded shape which is set when the fabric isheat treated. When the medical device springs back into this shape, itmay tend to act against the distal end of the delivery catheter,effectively urging itself forward beyond the end of the catheter. Thisspring action could conceivably result in improper positioning of thedevice. Since the threaded clamp connector or other securement deviceenables the operator to maintain control of the device duringdeployment, the shape-restoring spring action of the medical device canalso be controlled and the operator can maintain control over thedeployment to ensure proper positioning. A therapeutic medical device inaccordance with the invention may be delivered and properly placed usingtwo dimensional echocardiagraphy and Doppler color flow mapping.

Generally, then in accordance with the present invention, there isprovided further methods of treating physiological conditions ofpatients. In accordance with this method, a medical device suitable fortreating a condition of interest, (occlusion, filter, shunt or flowrestriction) which may be substantially in accordance with one of theembodiments outlined herein, is selected. For example, if a PatentDuctus Arteriosus (PDA) is to be treated, a PDA occlusion device similarto that of FIG. 15 or 21 can be assembled together and onto a deliverydevice. Once the appropriate medical device is assembled for delivery, acatheter may be positioned within a channel in the patient's body toplace the distal end of the catheter adjacent the desired treatmentsite, such as immediately adjacent (or even within) the passageway orchannel of the PDA. After proper placement of the PDA occlusion device,it may be detached and the delivery device and associated catheterwithdrawn.

While a preferred embodiment of the present invention has beendescribed, it should be understood that various changes, adaptations andmodifications may be made therein without departing from the spirit ofthe invention and the scope of the appended claims.

What is claimed is:
 1. A method of producing a collapsible medicaldevice comprising: providing a plurality of discrete interconnectablecomponents each having two ends, at least one of the componentscomprising a plurality of metal strands woven into a tubular metalfabric having a proximal end and a distal end, the tubular metal fabrichaving an expanded preset configuration; securing at least one end ofthe tubular metal fabric thereby gathering and inhibiting unraveling ofthe strands; providing a connector attached to each end of eachcomponent for connecting multiple components to one another or to adelivery system in a reversible manner, wherein each connector has thesame configuration; and assembling the medical device by connectingselected components together in a desired sequence.
 2. The method asrecited in claim 1, further comprising: at least partially disassemblingthe medical device to remove at least one of the components; andreassembling the medical device by replacing each component removed withanother component.
 3. The method as recited in claim 1, wherein theconnectors are threaded.
 4. The method as recited in claim 1, furthercomprising: incorporating at least one adaptor to make consecutiveconnectors compatible for assembly of the medical device.
 5. The methodas recited in claim 4, wherein the at least one adaptor has internalthreads adjacent a recess and each connector has an externally threadedend component, and wherein assembling the medical device by connectingselected components comprises threading the externally threaded endcomponent through the internal threads and into the recess.
 6. Themethod as recited in claim 1, wherein each connector includes asecurement end, and wherein securing at least one end of the tubularmetal fabric comprises securing each end of the tubular metal fabricusing the securement end.
 7. The method as recited in claim 1 furthercomprising: deploying the medical device in a patient; comparing themedical device with a patient's anatomy while the medical device isstill attached to a delivery device; withdrawing the medical device;disconnecting the medical device from the delivery device; and resizingthe medical device by replacing at least one of the components.
 8. Themethod as recited in claim 7, wherein deploying the medical device in apatient comprises: transitioning each component of the medical devicefrom the expanded preset configuration to an elongated reduced-diameterconfiguration; delivering the medical device into the patient using thedelivery device; and transitioning the medical device from the elongatedreduced-diameter configuration to the expanded preset configuration. 9.The method as recited in claim 1, wherein assembling the medical deviceby connecting selected components together in a desired sequencecomprises connecting the selected components in a longitudinalconfiguration along a common axis.
 10. The method as recited in claim 1,further comprising: fabricating the plurality of components.
 11. Themethod as recited in claim 10, further comprising: fabricating a firstcomponent with a first set of characteristics; and fabricating a secondcomponent with a second set of characteristics.
 12. The method asrecited in claim 1, wherein assembling the medical device by connectingselected components together comprises connecting a spacer componentbetween a first disk component and a second disk component.
 13. Themethod as recited in claim 1, wherein assembling the medical device byconnecting selected components together comprises connecting a spacercomponent between a first flange component and a second flangecomponent.
 14. The method as recited in claim 1, wherein assembling themedical device by connecting selected components together comprisesconnecting a spacer component between a first end component comprisingone of a disk and a flange and a second end component comprising one ofa disk and a flange.